Postpartum HemorrhageNCT01428817
Carbetocin at Elective Cesarean Delivery Part 2
A study testing Carbetocin in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Carbetocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients planned for elective cesarean delivery under spinal anesthesia.
- All patients who give written informed consent to participate in this study.
Who cannot join
- All patients who refuse to give written informed consent.
- All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.
- All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
- All patients with hepatic, renal, and vascular disease,
- All patients requiring general anesthesia prior to the administration of the study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)
Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.
Read the detailed description
The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery.
Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied.
The results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Carbetocin
- Keywords
- pregnancy, postpartum hemorrhage, Cesarean delivery, carbetocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Duratocin
20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
CarbetocinDrug
Also called Duratocin
40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
CarbetocinDrug
Also called Duratocin
60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
CarbetocinDrug
Also called Duratocin
80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
CarbetocinDrug
Also called Duratocin
100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin 20mcg | Active comparator | Not described Receives: Drug: Carbetocin |
| Carbetocin 40mcg | Active comparator | Not described Receives: Drug: Carbetocin |
| Carbetocin 60mcg | Active comparator | Not described Receives: Drug: Carbetocin |
| Carbetocin 80mcg | Active comparator | Not described Receives: Drug: Carbetocin |
| Carbetocin 100mcg | Active comparator | Not described Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine tone
The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).
Measured: 2 minutes
Secondary outcomes (3)
Uterine tone
Uterine tone will be assessed by palpation 2 hours post-delivery by the nurse/obstetrician in the recovery room.
Measured: 2 hours
Blood loss
Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section.
Measured: 48 hours
Side effects
Any of the following will be noted up to 2 hours post delivery: systolic blood pressure < 80% of pre-delivery values, tachycardia > 30% pre-delivery levels, bradycardia < 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428817
- Sponsor's protocol ID
- 11-02
- Status last verified
- Mar 2012
- First submitted
- 1 Sep 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Anandakrishnan S, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose, part 2. Can J Anaesth. 2013 Nov;60(11):1054-60. doi: 10.1007/s12630-013-0028-2. Epub 2013 Sep 25.
PubMed 24158878
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin at Elective Cesarean Delivery: A Dose Finding Study (Part 2)
- ClinicalTrials.gov ID
- NCT01428817
- Acronym / sponsor ID
- 11-02
- Conditions
- Postpartum Hemorrhage
- Keywords
- pregnancy, postpartum hemorrhage, Cesarean delivery, carbetocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-partum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most common uterotonic drug used to prevent and treat PPH in North America, however, there are some limitations to its use. Oxytocin has a very short duration of action, which requires a continuous infusion to achieve sustained uterotonic activity. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recently recommended a single 100mcg dose of carbetocin at elective Cesarean delivery to promote uterine contraction and prevent post partum hemorrhage (PPH), in lieu of the more traditional oxytocin regimens. Carbetocin lasts 4 to 7 times longer than oxytocin, with a similar side effect profile and apparent greater efficacy rate. However, a dose response to determine the minimum effective dose of carbetocin has not yet been published. The investigators hypothesize that the minimum effective dose (ED90) is above 20mcgs and below 80mcgs in women undergoing elective Cesarean delivery.
Detailed description
The Society of Obstetricians and Gynecologists of Canada (SOGC) recently recommended a 100mcg intravenous bolus dose of carbetocin following Cesarean delivery.
Studies thus far show that carbetocin may be just as effective as oxytocin in promoting uterine contraction, with a similar side effect profile. In addition, patients receiving carbetocin may experience less blood loss, and require less additional uterotonics when compared with oxytocin. A dose response study conducted by Cordovani et al suggested no difference in efficacy of uterine contraction for doses of carbetocin between 80-120mcg. Additionally, hypotension was noted for all dose groups studied.
The results of this follow-up study will define the minimum required dose of carbetocin for uterine contraction, thus minimizing unnecessary side effects, improving quality and safety of patient care. It may also contribute in establishing carbetocin as a substitute to oxytocin for elective cesarean section at our institution as well as others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Carbetocin 20mcg | Active comparator | Drug: Carbetocin |
| Carbetocin 40mcg | Active comparator | Drug: Carbetocin |
| Carbetocin 60mcg | Active comparator | Drug: Carbetocin |
| Carbetocin 80mcg | Active comparator | Drug: Carbetocin |
| Carbetocin 100mcg | Active comparator | Drug: Carbetocin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients planned for elective cesarean delivery under spinal anesthesia.
- All patients who give written informed consent to participate in this study.
Key exclusion criteria (5 listed)
- All patients who refuse to give written informed consent.
- All patients who claim allergy or hypersensitivity to carbetocin or oxytocin.
- All patients with conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia, polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
- All patients with hepatic, renal, and vascular disease,
- All patients requiring general anesthesia prior to the administration of the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbetocinAlso: Duratocin20mcg carbetocin, IV, over 1 minute following delivery of the fetal head. | Drug | Carbetocin 20mcg |
| CarbetocinAlso: Duratocin40mcg carbetocin, IV, over 1 minute following delivery of the fetal head. | Drug | Carbetocin 40mcg |
| CarbetocinAlso: Duratocin60mcg carbetocin, IV, over 1 minute following delivery of the fetal head. | Drug | Carbetocin 60mcg |
| CarbetocinAlso: Duratocin80mcg carbetocin, IV, over 1 minute following delivery of the fetal head. | Drug | Carbetocin 80mcg |
| CarbetocinAlso: Duratocin100mcg carbetocin, IV, over 1 minute following delivery of the fetal head. | Drug | Carbetocin 100mcg |
Primary outcome
Uterine tone
Time frame: 2 minutes
The obstetrician will assess uterine tone by palpation. Uterine tone will be rated as satisfactory (firm) or unsatisfactory (boggy).
3 secondary outcomes
Uterine tone
Time frame: 2 hours
Blood loss
Time frame: 48 hours
Side effects
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
- Derived from this study: PubMed 24158878Anandakrishnan S, Balki M, Farine D, Seaward G, Carvalho JC. Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose, part 2. Can J Anaesth. 2013 Nov;60(11):1054-60. doi: 10.1007/s12630-013-0028-2. Epub 2013 Sep 25.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbetocin in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine tone (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.